Independent control laboratories

The manufacturer of a medicinal product for human or veterinary use, including clinical trial material, is responsible for establishing and maintaining a quality control system to perform the necessary tests on raw materials, finished products and production facilities.

These tests are carried out at different stages of the production process:

• raw materials and starting materials including active pharmaceutical ingredients, excipients, process water and packaging materials
• intermediate products such as bulk tablets and capsules, granules, liquids and creams
• finished medicinal products in final packaging
• stability studies
• microbiological testing of production premises (environmental hygiene).

The tests must be carried out in accordance with GMP, in most cases in the manufacturer’s own laboratories under the manufacturing authorisation issued by the Swedish MPA.

Independent control laboratory

The manufacturer may choose to outsource all or some of the quality control activities to an independent control laboratory.

The manufacturer is responsible for ensuring that:

• a contracted independent quality control laboratory works according to GMP
• a technical agreement/contract is drawn up that regulates the responsibilities between the principal and the contractor
• the control laboratory is competent to carry out the task, for example by carrying out self inspections.

New interpretation and changed rules for independent control laboratories

Historically, manufacturing authorisations for independent control laboratories in Sweden performing QC tests for release of pharmaceuticals, have not been required. Instead, GMP certificates have been issued.

However, Swedish MPA has changed its interpretation resulting in a requirement for independent quality control laboratories to have a manufacturing authorisation for human medicinal products and investigational products. The changed interpretation is described in a request from the Swedish MPA to the Ministry of Health and Social Affairs, diary number 1.1.5-2021-009913. Contact the registrar if you want to read this request.

EU regulation 2019/6 on veterinary medicinal products states that a manufacturing authorisation is required for the control of such products. In this instance, the regulations have changed and not Swedish MPA’s interpretation.

Who, and what types of controls, are required to have authorisation?

Only independent control laboratories in Sweden are subject to the requirement for a manufacturing authorisation. If the laboratory is situated in another country in the EEA, the rules of that Member State apply.

The requirement for authorisation applies to laboratories that carry out quality control tests forming the basis for product release, i.e. such test that are part of the medicinal product's specification. For analyses and storage of samples in on-going stability programme and pivotal stability studies, a manufacturing authorisation is not required. Authorisation is also not required for analyses of raw materials used for pharmaceutical manufacturing. As before, however, such analyses must still be carried out according to good manufacturing practice for medicinal products.

A Qualified Person is required for a manufacturing authorisation

Whoever holds an authorisation for the manufacture of medicinal products must have a Qualified Person (QP).

A QP for medicinal products for human use must fulfill the requirements of 13 § Swedish MPA's provisions (HSLF-FS 2021:102) on authorisation for the manufacture and import of medicinal products. A QP for veterinary medicinal products must meet the requirements of Article 97(2) and 97(3) of Regulation (EU) 2019/6 of the European Parliament and of the Council.

The applicant needs to demonstrate that the proposed QP has the competence required. For each individual course listed as requirements for a QP for human medicinal products, the applicant should justify the suggested QP’s competence. The extent of knowledge required in each subject needs to be evaluated based on the specific activities that the application covers. As stated in 13 § HSLF-FS 2021:102, it is possible to prove knowledge in the relevant course in other ways than by diplomas, or by other certificates.

The responsibilities of a Qualified Person for an independent quality control laboratory

Quality control is an integral part of the manufacturing of medicinal products. A QP for a control laboratory must have overall control over the operations and the test results obtained. The review for the release of test results may be carried out by other staff, but the QP must exercise overall control over the quality of the results and the methods used.

The responsible manufacturer listed in the medicinal product's marketing authorisation, i.e. for which the batch certifying QP works, has the overall responsibility for the batch and must have agreements with all manufacturers involved in the manufacturing chain, including contract laboratories. The agreement should describe the QP responsibilities for each contract manufacturing operation.

Authorisation is required from 1 January, 2024

As of January 1, 2024, independent contract laboratories must have a manufacturing authorisation. An application should therefore be made as soon as possible so it may be processed, and allowing a possible inspection to be carried out, in time. Application for a manufacturing authorisation is specified on the pages “Manufacturing of medicinal products” and “Investigational medicinal products”.

Please note that you need to apply for separate authorisations for the manufacture of medicinal products for humans, medicinal products for animals, investigational medicinal products for humans and investigational medicinal products for animals, if you carry out test for all these types of medicinal products. The rules for good manufacturing practice for the different types of medicinal products are specified in several different regulations, which are, however, very similar.

The application is subject to a fee. According to chapter 2, paragraph 8 of Ordinance (2010:1167) on fees for the governmental control of medicinal products, the person applying for an authorisation to manufacture pharmaceuticals is required to pay SEK 60,000 per manufacturing site. When applying for authorisation for several types of medicinal products, only one fee is paid. If, on the other hand, the control laboratory is located on several different sites (different addresses), separate applications must be made, and the fee paid, per address.

The authorisation is also subject to an annual fee. The annual fee is the same as the application fee and is charged per address that holds an authorisation according to chapter 4 paragraph 2 of the same regulation as above.